Professional Documents
Culture Documents
Results Last
Results Last
the clinical and radiographic success of Biodentine,Tricalcium phosphate with and without
Simvastatin, when used as pulpotomy agents in primary molars.
Between group Within group Comparison
comparison
Included Missing Included Missing Total
Biodentine 3 Months 15 0 13 2 15
6 Months 13 2 13 2 15
9 Months 13 2 13 2 15
B+S 3 Months 15 0 12 3 15
6 Months 12 3 12 3 15
9 Months 12 3 12 3 15
TCP 3 Months 15 0 12 3 15
6 Months 12 3 12 3 15
9 Months 12 3 12 3 15
TCP+S 3 Months 15 0 13 2 15
6 Months 13 2 13 2 15
9 Months 13 2 13 2 15
Total 50 10 60
STATISTICAL ANALYSIS:
Data was entered into Microsoft® Excel and analysed using R software ver 3.1. Continuous
variables were expressed as Mean & Standard Deviation, Categorical variables were expressed
as frequencies & percentages (Proportions). Within group analysis of categorical variables as
paired Proportions were done using Cochran’s Q test. Between group comparison of
independent proportions were done using Chi Square/Fisher Exact test. P value ≤0.05 was
considered statistically significant
RESULTS
Table 1a: Descriptive statistics of the Study Group (At Recruitment)
N Percent %
Gender Female 30 50
Male 30 50
Age (Group) 4-6 Years 17 28.3
7-9 Years 43 71.7
Material Biodentine 15 25
B+S 15 25
TCP 15 25
TCP+S 15 25
Total 60 100
There were 25 (50) males & 25 (50) females after excluding lost to follow up cases with 12
(24) subjects in 4-6 years age group and 38(76) in 7-9 years age group. The mean (SD) age of
study subjects was 7.08 (1.4) years, with minimum of 4 years & maximum of 9 years. 13 (26),
12 (24), 12(24), 13(24) subjects were included in Biodentine, B+S, TCP, TCP+S groups
respectively
Gender
25 25
50% 50%
Female
Male
Age Group
12
24%
4-6 Years
38 7-9 Years
76%
Table 2: Study subjects in each Group at each clinical follow up
Clinical Outcome 3 Months 6 Months 9 Months
n (%) n (%) n (%)
Biodentine PAIN Absent 14 (93.3) 11 (84.6) 11 (84.6)
Present 1 (6.7) 2 (15.4) 2 (15.4)
PERCUSSION Absent 14 (93.3) 11 (84.6) 11 (84.6)
Present 1 (6.7) 2 (15.4) 2 (15.4)
SWELLING Absent 14 (93.3) 12 (92.3) 11 (84.6)
Present 1 (6.7) 1 (7.7) 2 (15.4)
FISTULA Absent 14 (93.3) 11 (84.6) 11 (84.6)
Present 1 (6.7) 2 (15.4) 2 (15.4)
PM Absent 14 (93.3) 11 (84.6) 11 (84.6)
Present 1 (6.7) 2 (15.4) 2 (15.4)
Total 15 (100) 13 (100) 13 (100)
B+S PAIN Absent 15 (100) 12 (100) 12 (100)
Present 0 (0) 0 (0) 0 (0)
PERCUSSION Absent 15 (100) 12 (100) 12 (100)
Present 0 (0) 0 (0) 0 (0)
SWELLING Absent 15 (100) 12 (100) 12 (100)
Present 0 (0) 0 (0) 0 (0)
FISTULA Absent 15 (100) 12 (100) 12 (100)
Present 0 (0) 0 (0) 0 (0)
PM Absent 15 (100) 12 (100) 12 (100)
Present 0 (0) 0 (0) 0 (0)
Total 15 (100) 12 (100) 12 (100)
TCP PAIN Absent 13 (86.7) 9 (75) 9 (75)
Present 2 (13.3) 3 (25) 3 (25)
PERCUSSION Absent 13 (86.7) 9 (75) 9 (75)
Present 2 (13.3) 3 (25) 3 (25)
SWELLING Absent 13 (86.7) 10 (83.3) 9 (75)
Present 2 (13.3) 2 (16.7) 3 (25)
FISTULA Absent 13 (86.7) 9 (75) 9 (75)
Present 2 (13.3) 3 (25) 3 (25)
PM Absent 13 (86.7) 9 (75) 9 (75)
Present 2 (13.3) 3 (25) 3 (25)
Total 15 (100) 12 (100) 12 (100)
TCP+S PAIN Absent 13 (86.7) 9 (69.2) 9 (69.2)
Present 2 (13.3) 4 (30.8) 4 (30.8)
PERCUSSION Absent 13 (86.7) 9 (69.2) 9 (69.2)
Present 2 (13.3) 4 (30.8) 4 (30.8)
SWELLING Absent 13 (86.7) 10 (76.9) 9 (69.2)
Present 2 (13.3) 3 (23.1) 4 (30.8)
FISTULA Absent 13 (86.7) 9 (69.2) 9 (69.2)
Present 2 (13.3) 4 (30.8) 4 (30.8)
PM Absent 15 (100) 9 (69.2) 9 (69.2)
Present 0 (0) 4 (30.8) 4 (30.8)
Total 15 (100) 13 (100) 13 (100)
Follow up for clinical parameters was done at 3, 6 & 9 Months and there were 15, 13, 13
subjects in Biodentine & TCP+S groups, 15, 12, 12 in Biodentine+S & TCP subjects
respectively
During the follow up at 3, 6 & 9 Months , pain was present in (6.7), 2 (15.4), 2 (15.4) subjects,
percussion in 1 (6.7), 2 (15.4), 2 (15.4) subjects, swelling in 1 (6.7), 1 (7.7), 2 (15.4) subjects,
fistula in 1 (6.7), 2 (15.4), 2 (15.4) subjects, PM in 1 (6.7), 2 (15.4), 2 (15.4) subjects
respectively in biodenitne group.
IN B+S group all clinical parameters were absent in all subjects at every follow up.
IN TCP group Pain, Percussion, Fistula & PM were present in 2 (13.3), 3 (25), 3 (25) subjects
and swelling in 2 (13.3), 2 (16.7), 3 (25) subjects respectively at 3, 6, 9 months
In TCP+S group pain, percussion & fistula was present in 2 (13.3), 4 (30.8), 4 (30.8) subjects,
swelling in 2 (13.3), 3 (23.1), 4 (30.8)subjects, PM in 0 (0), 4 (30.8), 4 (30.8) subjects
respectively at 3, 6, 9 months.
10
8
6
4
2 2 2 2 2 2 2 2 2
2 1 1 1 1 1 1
0
16 15 15 15 15 15
14 12 12 12 12 12 12 12 12 12 12
12
10
8
6
4
2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0
14 13 13 13 13 13
12
10
10 9 9 9 9 9 9 9 9 9
8
6
4 3 3 3 3 3 3 3 3 3
2 2 2 2 2 2
2
0
15
16
13 13 13 13
14
12 10
9 9 9 9 9 9 9 9 9
10
8
6 4 4 4 4 4 4 4 4 4
4 3
2 2 2 2
2 0
0
Follow up for Radiological parameters was done at 3, 6 & 9 Months and there were 15, 13, 13
subjects in Biodentine & TCP+S groups, 15, 12, 12 in Biodentine+S & TCP subjects
respectively
Pathological interradicular radiolucency was present in 2 (13.3), 4 (30.8), 4 (30.8) subjects,
Internal root resorption, External root resorption, widening of periodontal ligament space in 1
(6.7), 4(30.8), 4 (30.8) subjects and Canal calcification in 1 (6.7), 1 (8.3), 1 (8.3) subjects all
respectively at 3, 6, 9 months follow up in Biodentine group
In B+S group Pathological interradicular radiolucency was present in 2 (13.3), 3 (25), 2 (16.7)
subjects, Internal root resorption, widening of periodontal ligament space in 0 (0), 2 (16.7),
1 (8.3) subjects, External root resorption in 0 (0), 0 (0), 1 (8.3) subjects and Canal
calcification in 1 (6.7), 1(8.3), 1 (8.3) subjects respectively at 3, 6, 9 months follow up.
With TCP there were 6 (40), 6 (50), 6 (50) subjects with Pathological interradicular
radiolucency, 2(13.3), 3 (25), 4 (33.3) subjects had Internal resorption, 2 (13.3), 3 (25), 5 (41.7)
subjects had external resorption, 2 (13.3), 2 (16.7), 3 (25) subjects had widening of periodontal
ligament space & Canal calcification at 3 months, 6 months and 9 months follow up
respectively.
With TCP+S there were 4 (26.7), 5 (38.5), 5 (38.5) subjects with Pathological interradicular
radiolucency, 2 (13.3), 3 (23.1), 4 (30.8)subjects had Internal resorption, 3 (20), 4 (30.8),
5(38.5) subjects had external resorption, 2 (13.3), 4 (30.8), 4 (30.8) subjects had widening of
periodontal ligament space & Canal calcification at 3 months, 6 months and 9 months follow
up respectively.
Outcome of Radiological Parameters with Biodentine
Absent Present
14 14 14 14
14 13
12 11
10 10 10
10 9 9 9 9 9 9
8
6
4 4 4 4 4 4
4 3 3 3
2 2
2 1 1 1 1
0
16 15 15 15
14
14 13
12
12 11 11 11 11 11
10 10 10
10 9
8
6
4 3
2 2 2 2
2 1 1 1 1 1 1
0 0 0 0
0
13 13 13 13
14
12 10 10
9 9 9 9 9
10 8
7
8 6 66 66
6 5
4
4 3 3 3 3
2 2 2 2 2 2
2
0
13 13 13
14 12
11
12 10
9 9 9 9 9 9
10 8 8 8
8
6 5 5 5
4 4 4 4 4 4 4
4 3 3
2 2 2
2
0
In biodentine group Clinical success (as defined by absence of any of clinical signs/symptoms)
was observed in 12 (92.3) subjects at 3 months, 11 (84.6) subjects at 6 months & 9 months.
This observation was not statistically significant (Cochran’s Q=2, p=0.368).
In B+S group Clinical success was seen in all cases at 3, 6 and 9 months
In TCP group Clinical success was observed in10 (83.3) subjects at 3 months, 9 (75) at 6
months & 9 months. There was no statistically significant difference in clinical success rate at
3, 6 & 9 months follow up times. (Cochran’s Q=2, p=0.368).
Similarly, there was no statistically significant difference in clinical success rate with TCP+S
at 3, 6, 9 months follow up (Cochran’s Q=4, p=0.135), with observed success in 11 (84.6), 9
(69.2), 9 (69.2) subjects respectively at 3, 6, 9 months.
8
6
4 4
4 3 3
2 2 2 2
2 1
0 0 0
0
The Radiological success (as defined by absence of any of radiological signs) rate was 92.3
percent at 3 months and reduced to 69.2 percent at 6 months and remained same at 9 months.
This observation was marginally statistically significant (Cochran’s Q=6, p=0.05).
In B+S group Radiological success was seen in 10 (83.3), 9 (75), 10 (83.3) cases at 3, 6 and 9
months respectively. This difference was not statistically significant (Cochran’s Q=1,
p=0.607).
In TCP Radiological success was observed in 7 (58.3) subjects at 3 months, in 6 (50) subjects
at 6 months & 9 months. There was no statistically significant difference in radiological success
rate between the follow up times. (Cochran’s Q=2, p=0.368).
Similarly, there was no statistically significant difference in radiological success rate with
TCP+S between 3, 6, 9 months follow up (Cochran’s Q=2, p=0.368), with observed success in
9 (69.2), 8 (61.5), 8 (61.5) subjects respectively at 3, 6, 9 months.
Inference:
1. Radiological Success rate is marginally (Slightly) more at 3 months compared to
6 months & 9 months with Biodentine
2. There is no change in radiological success rate with time with B+S, TCP & TCP+S.
Radiological outcome at 3, 6 and 9 months in each group
Success Failure
12
12
10 10
10 9 9 9 9
8 8
8 7
66 66
6 5 5 5
4 4 4
4 3
2 2
2 1
At 3 months 14 (93.3) subjects in Biodentine group, 15 (100) subjects in B+S group, 13 (86.7)
subjects in TCP group and 13 (86.7) subjects in TCP+S group had clinical success. This
difference in clinical success rate with different pulpotomy agents was not statistically
significant as analysed by fisher exact test (P=0.740).
11 (84.6) subjects in Biodentine group, 12 (100) subjects in B+S group, 9 (75) subjects in
TCP group and 9 (69.2) subjects in TCP+S group had clinical success both at 6 months and 9
months. This difference in clinical success rate at 6 months & 9 months with different
pulpotomy agents was not statistically significant (P=0.204).
Inference: All four Pulpotomy agents are similar with reference to clinical success
Clinical outcome at each Follow up
Success Failure
16 15
14
14 13 13
12 12
12 11 11
10 9 9 9 9
8
6 4 4
4 3 3
2 2 2 2
2 1
0 0 0
0
At 3 months 13 (86.7) subjects in Biodentine group, 12 (80) subjects in B+S group, 9 (60)
subjects in TCP group and 10 (66.7) subjects in TCP+S group had Radiological success. This
difference in Radiological success rate with different pulpotomy agents was not statistically
significant (P=0.402).
9 (69.2) subjects in Biodentine group, 9 (75) subjects in B+S group, 6 (50) subjects in TCP
group and 8(61.5) subjects in TCP+S group had radiological success at 6 months. This
difference in success rate at 6 months between pulpotomy agents was not statistically
significant (P=0.620).
At 9 months 9 (69.2) subjects in Biodentine group, 10 (83.3) subjects in B+S group, 6 (50)
subjects in TCP group and 8(61.5) subjects in TCP+S group had radiological success. This
difference was not statistically significant (P=0.392).
Inference: All four Pulpotomy agents are similar with reference to Radioloigcal success
13
14 12
12 10 10
9 9 9 9
10 8 8
8 6 66 66
5 5 5
6 4 4
3 3
4 2 2
2
0
With overall clinical success (defined as absence of any clinical signs/symptoms at any follow
up) rate of 84.6 %, 100 %, 75% & 69.2 % with Biodentine, B+S, TCP & TCP+S respectively,
there was no statistically significant difference in overall clinical outcome among the four
materials (P=0.204).
Inference: All pulpotomy materials were similar with respect to overall clinical outcome
Overall Clinical Outcome in Four Groups
Success Failure
12
12 11
10 9 9
8
Number
6
4
4 3
2
2
0
0
Biodentine B+S TCP TCP+S
With overall radiological success (defined as absence of any Radiologicl signs at any follow
up) in 9 (69.2), 10 (83.3), 6(50), 8(61.5) subjects in Biodentine, B+S, TCP & TCP+S groups
respectively, there was no statistically significant difference in overall radiological outcome
among the four materials (P=0.392).
Inference: All pulpotomy materials were similar with respect to overall radiological
outcome
Overall Radiological Outcome in Four Groups
Success Failure
10
10 9
9 8
8
7 6 6
6 5
Number
5 4
4
3 2
2
1
0
Biodentine B+S TCP TCP+S
Table 10: Comparison of Overall outcome among the groups
Overall Biodentine B+S TCP TCP+S Total Fisher exact test
Success 9 (69.2) 10 (83.3) 6 (50) 8 (61.5) 33 (66) P=0.392
Failure 4 (30.8) 2 (16.7) 6 (50) 5 (38.5) 17 (34) (Not Significant)
Total 13 (100) 12 (100) 12 (100) 13 50
(100) (100)
5 4
4
3 2
2
1
0
Biodentine B+S TCP TCP+S
The overall success (Absence of any clinical/Radiological findings at any follow up) with
Biodentine, B+S, TCP & TCP+S was observed in 9 (69.2), 10 (83.3), 6 (50), 8 (61.5) subjects
respectively. This difference in overall success among the four groups was not statistically
significant (P=0.392)
Inference: All pulpotomy materials were similar with respect to overall outcome